FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Novo Nordisk PADE Reporting Violations

[ Price : $8.95]

FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.

CGMP Violations at Fareva Morton Grove

[ Price : $8.95]

FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility...

FDA Issues Early Alert on Erbe Flexible Cryoprobes

[ Price : $8.95]

FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that som...

Hims & Hers Super Bowl Ad Hit

[ Price : $8.95]

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement act...

FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

[ Price : $8.95]

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are li...

Updated Guidance Clarifies Biosimilar Development Requirements

[ Price : $8.95]

FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.

Incyte Gets Complete Response Over Catalent Inspection Issues

[ Price : $8.95]

FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspectio...

Group urges Pfizer to Retract Threat on Drug Supplies

[ Price : $8.95]

Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by C...

Roche Breast Cancer Drug Misses Endpoint in Late-Stage Trial

[ Price : $8.95]

Roche reports that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in...

FDA Meets with States to Advance Canada Importation Plan

[ Price : $8.95]

FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of...